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CathWorks FFRangio™ is a software device for the clinical quantitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio™, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio™ analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of coronary arteries physiology. The results of CathWorks FFRangio™ are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional evaluation.

FFRancio uses standard angiographic images that are retrieved from the X-ray Imaging System (C-arm) in DICOM format. The user selects the images and, following the system prompts, marks key features on the images including the target lesion, ostium location, main vessel, target vessel, and its side branches. The system then matches the corresponding vessels among the projections and generates a 3D computer model of the vessels. The 3D model is used for blood flow analysis and determination of the FFRangio.

The modified FFRangio system, designated as model FAU4000, consists of the following components:

• Touch screen control console located either as a fixed installation in the cath lab on . an extension arm mounted on the wall or from the ceiling, or on a desktop or mobile cart in the cath lab or control room
• Processing Unit located in the cath lab machine room / control room ●
• 3D Mouse located at the patient bedside ●
• Connection Box located in either the cath lab or control room ●

The system supports optional visual media output to the cath lab main displays, so the system GUI may be observed on both the system's Console display and on the cath lab's main display (boom monitor).

The provided text describes a Special 510(k) submission for the FFRangio System, focusing on hardware and software changes to a previously cleared device. Therefore, the information regarding the acceptance criteria and the study proving the device meets these criteria primarily refers to the original FFRangio System (K182149), as the current submission (K192442) asserts that the changes do not affect the fundamental scientific technology or the indications for use.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The core performance metrics presented are Sensitivity and Specificity, which were established during the pivotal clinical study of the predicate (original) FFRangio System.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set of the original pivotal clinical study, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions "the FFRangio pivotal clinical study."

For the current 510(k) submission (K192442), which pertains to modifications, the performance data cited is from the previous clearance. The specific tests conducted for this Special 510(k) (e.g., software validation, electrical safety, human factors) are not for clinical performance.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not provide details on the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the pivotal clinical study. It refers to the FFRangio pivotal clinical study generally.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method (e.g., 2+1, 3+1, none) used for the test set of the original pivotal clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to show how much human readers improve with AI vs. without AI assistance. The described "FFRangio pivotal clinical study" provided standalone performance metrics (sensitivity and specificity).

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was implicitly done, as the sensitivity and specificity values are presented as performance characteristics of the FFRangio system itself, independent of human-in-the-loop performance improvement. These metrics ("Sensitivity* and specificity are the per vessel estimates as determined from the FFRangio pivotal clinical study") describe the algorithm's diagnostic accuracy.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the FFRangio pivotal clinical study.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established.

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CathWorks FFRangio™ is a software device for the clinical quantitative and qualitative analysis of previously acquired angiography DICOM data for patients with coronary artery disease. It provides FFRangio™, a mathematically derived quantity, computed from simulated blood flow information obtained from a 3D computer model, generated from coronary angiography images. FFRangio™ analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided as a supportive aid for qualified clinicians in the evaluation and assessment of coronary arteries physiology. The results of CathWorks FFRangio™ are intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional evaluation.

The FFRangio™ system is a computer system installed on a mobile cart that is to be located inside the catheterization room or in an adjacent technical/viewing area. The cart holds the computer processing unit, user interface control station (LCD screen and keyboard/mouse), medical isolation transformer, and network isolator. Operation requires only connections to mains and a DICOM communication port. The system supports optional visual media output to the Cath Lab main displays, so the system GUI may be observed on both the system's LCD display and on the Cath Lab's main display (boom monitor).

FFRancio™ uses standard angiographic images (angiograms) that are retrieved from the X-ray Imaging System (C-arm) in DICOM format. The user selects the images and, following the system prompts, marks key features on the images including the target lesion, ostium location, main vessel, target vessel, and its side branches. The system then matches the corresponding vessels among the projections and generates a 3D computer model of the vessels. The 3D model is used for blood flow analysis and determination of the FFRangio.

Here's a breakdown of the acceptance criteria and study details for the CathWorks FFRangio™ system, based on the provided text:

Acceptance Criteria and Device Performance

Notes:

• The reported performance for Sensitivity and Specificity includes the lower one-sided 95% confidence interval, which was used to determine if the device met the pre-specified target goals. Both were significantly above the targets.
• The correlation coefficient, intercept, and slope were secondary endpoints, and their direct "performance goals" are stated along with the achieved values.

Study Information

The primary study referenced is the FAST-FFR Trial.

2. Sample Size and Data Provenance:

• Test Set (Efficacy Analysis): 301 adult subjects and 319 coronary lesions.
• Study Enrollment: 382 subjects (30 roll-in, 352 study subjects).
• Data Provenance: Prospective, multicenter, international trial conducted at 10 sites in 5 countries: United States, Europe, and Israel.
  • 124 subjects (32.5%) were enrolled at sites in the United States.

3. Number and Qualifications of Experts for Test Set Ground Truth:

The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience) for establishing the ground truth of the invasive FFR. However, it does state:

• "All invasive FFR data were reviewed post-hoc by an independent FFR physiology core laboratory."

4. Adjudication Method for Test Set:

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for the test set's ground truth by the independent FFR physiology core laboratory. It simply states that the data was "reviewed."

Furthermore, it states for the FFRangio™ data:

• "all FFRangio™ data were reviewed post-hoc by a core laboratory at CathWorks."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not explicitly mentioned or presented in the provided text. The study primarily focused on the standalone diagnostic accuracy of the FFRangio™ system compared to invasive FFR.

6. Standalone (Algorithm Only) Performance:

• Yes, a standalone performance study was conducted. The FAST-FFR trial specifically evaluated the FFRangio™ system's accuracy as compared to invasive wire FFR, with on-site hospital users blinded to the invasive FFR and the FFRangio™ not being used for diagnostic or clinical decisions. This demonstrates the algorithm's performance independent of real-time human-in-the-loop influence on clinical decisions.

7. Type of Ground Truth Used:

• Invasive Wire FFR: The ground truth for the test set was obtained from "invasive wire FFR" measured using a coronary pressure wire and hyperemic stimulus. This is considered the gold standard for FFR measurement.

8. Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set used to develop the FFRangio™ algorithm. It mentions two clinical studies:
  • A two-phase validation study using an "earlier version of the operator interface but the same image processing and computation algorithms as the final device." This study analyzed "203 coronary lesions" and demonstrated sensitivity, specificity, and diagnostic accuracy. While this study helped validate the algorithms, it's not explicitly labeled as the training set.
  • The FAST-FFR trial (the pivotal study), which serves as the test set.

9. How the Ground Truth for the Training Set Was Established:

• Similar to the training set size, the document does not explicitly detail how the ground truth for an independent training set was established.
  • The "two-phase validation study" mentioned in point 8, which used an earlier version of the algorithm, compared FFRangio™ to "invasive FFR obtained from patients already scheduled for coronary assessment in the cath lab." This suggests invasive FFR was used as ground truth for that prior validation, which likely informed the development and refinement of the final algorithm's "image processing and computation algorithms." However, a specific training set and its ground truth acquisition are not explicitly isolated in the provided text.

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